Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients
29. september 2014 opdateret af: Michael A. Horst, PhD, MPHS, MS, Lancaster General Hospital
This research study is a prospective, randomized, blinded, placebo controlled trial evaluating the benefit of IV acetaminophen (Ofirmev™) as adjuvant analgesia in geriatric hip fracture patients.
IV acetaminophen has received FDA approval.
IV acetaminophen does not have the liver toxicity as oral acetaminophen.
No oral acetaminophen will be administered.
All patients diagnosed with a hip fracture aged at least 65 years and expected to undergo surgical intervention are eligible to participate.
Hip fractures affect greater than 300,000 geriatric patients annually, representing the second leading cause of hospitalization for this patient population.
Pain control in these patients is often problematic due to co-morbidities and changes in their pharmacokinetic and pharmacodynamic profiles.
Subjects may receive the normal DVT prophylactic treatments post-op.
Studieoversigt
Status
Trukket tilbage
Intervention / Behandling
Detaljeret beskrivelse
Approximately 46 subjects will be enrolled at LGH. Subjects will be randomized 1:1 to receive either IV acetaminophen 1000 mg q6 hours (FDA recommended dose) or IV placebo.
While receiving the study drug/placebo the subject's blood pressure, heart rate, respiratory rate, & pain intensity will be monitored.
Additional pain meds will be given if needed.
Study treatment will continue until subject is taken into the operating room; at that time the intervention will be discontinued and other pain medication will be provided.
Participation in the study will end at time of discharge from the hospital.
Researchers are expecting a 33% decrease in opioid use for subjects randomized to treatment group.
Undersøgelsestype
Interventionel
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Pennsylvania
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Lancaster, Pennsylvania, Forenede Stater, 17604
- Lancaster General Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
65 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- All patients aged at least 65 years with a diagnosis of hip fracture with whom surgical intervention is expected
- Patients with the following surgeons ( David Hughes MD, Gerald Rothacker MD, Frank Essis MD, James Carson MD, Michael Gish MD, Vincent Battista MD)
Exclusion Criteria:
- Documented drug or alcohol addiction or abuse
- Documented serum sodium levels > 145 mmol/L
- Documented serum chloride levels > 107 mmol/L
- Impaired liver function defined as an ALT or AST > 3 times the upper limit of normal, Child-Pugh class C, or patients with documented active liver disease
- Known allergy or intolerance to acetaminophen
- Weight ≤ 50 kg
- Creatinine clearance (CrCl) ≤ 30 ml/min as determined by the Cockcroft-Gault equation
- Documented dementia
- Acetaminophen (> 650 mg) or opioid (> 7 mg IV morphine equivalence) use within the previous 24 hours
- Documented chronic opioid use
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Placebo komparator: Placebo
For the control group, a total of 100 mLs of 0.9% sodium chloride will be transferred to a Hospira LifeCare container and infused over 15 minutes (6.7 mL/min).
A beyond use expiration of 6 hours will be placed on the container.
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For the control group, a total of 100 mLs of 0.9% sodium chloride will be transferred to a Hospira LifeCare container and infused over 15 minutes (6.7 mL/min).
A beyond use expiration of 6 hours will be placed on the container.
All admixture manipulations will be completed by the pharmaceutical staff according to the chapter 797 guidelines in the U.S. Pharmacopoeia.
The treatment period will begin after admission and randomization, and will continue until surgical intervention.
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Aktiv komparator: Acetaminophen treatment
For the treatment group, a total of 100 milliliters (mLs) of acetaminophen (1000 mg) will be transferred to a Hospira LifeCare container and infused over 15 minutes (6.7 mLs/min).
A beyond use expiration of 6 hours at room temperature will place on the container, as recommended by the manufacturer.
|
For the treatment group, a total of 100 milliliters (mLs) of acetaminophen (1000 mg) will be transferred to a Hospira LifeCare container and infused over 15 minutes (6.7 mLs/min).
A beyond use expiration of 6 hours at room temperature will place on the container, as recommended by the manufacturer.
All admixture manipulations will be completed by the pharmaceutical staff according to the chapter 797 guidelines in the U.S. Pharmacopoeia.
The treatment period will begin after admission and randomization, and will continue until surgical intervention.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Opioid usage
Tidsramme: 24 Hours
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Participants will be assessed for opioid utilization until they go to surgery: an average of 24 hours.
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24 Hours
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Length of stay
Tidsramme: Up to 1 week
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Participants will be followed for the duration of their hospital stay, an expected average of 1 week.
Length of stay, vital signs (blood pressure, heart rate, respiratory rate), pain scores using the visual analog scale (VAS), and opioid induced side effects including: nausea, vomiting, changes in blood pressure and delirium
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Up to 1 week
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Vital signs
Tidsramme: Up to 1 week
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Participants will be followed for the duration of their hospital stay, an expected average of 1 week.
Length of stay, vital signs (blood pressure, heart rate, respiratory rate), pain scores using the visual analog scale (VAS), and opioid induced side effects including: nausea, vomiting, changes in blood pressure and delirium
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Up to 1 week
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Pain scores
Tidsramme: Up to 1 week
|
Participants will be followed for the duration of their hospital stay, an expected average of 1 week.
Length of stay, vital signs (blood pressure, heart rate, respiratory rate), pain scores using the visual analog scale (VAS), and opioid induced side effects including: nausea, vomiting, changes in blood pressure and delirium
|
Up to 1 week
|
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Opioid induced side effects
Tidsramme: Up to 1 week
|
Participants will be followed for the duration of their hospital stay, an expected average of 1 week.
Length of stay, vital signs (blood pressure, heart rate, respiratory rate), pain scores using the visual analog scale (VAS), and opioid induced side effects including: nausea, vomiting, changes in blood pressure and delirium
|
Up to 1 week
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Jennifer L Costello, PharmD, Lancaster General Hospital
- Ledende efterforsker: Gerald W Rothacker, MD, Lancaster General Hospital
- Ledende efterforsker: Jason Hall, PharmD, Lancaster General Hospital
- Ledende efterforsker: Jill Rebuck, PharmD, Lancaster General Hospital
- Ledende efterforsker: Michael A Horst, PhD, Lancaster General Hospital
- Ledende efterforsker: Melody Dillman, RN, Lancaster General Hospital
- Ledende efterforsker: Michael Gish, MD, Lancaster General Hospital
- Ledende efterforsker: Vincent Batista, MD, Lancaster General Hospital
- Ledende efterforsker: James H Carson, MD, Lancaster General Hospital
- Ledende efterforsker: Frank M Essis, MD, Lancaster General Hospital
- Ledende efterforsker: David P Hughes, MD, Lancaster General Hospital
- Ledende efterforsker: Heidi L Testa, RN, Lancaster General Hospital
- Ledende efterforsker: LouAnne Kruse, RN, Lancaster General Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Pettersson PH, Jakobsson J, Owall A. Intravenous acetaminophen reduced the use of opioids compared with oral administration after coronary artery bypass grafting. J Cardiothorac Vasc Anesth. 2005 Jun;19(3):306-9. doi: 10.1053/j.jvca.2005.03.006.
- Chau DL, Walker V, Pai L, Cho LM. Opiates and elderly: use and side effects. Clin Interv Aging. 2008;3(2):273-8. doi: 10.2147/cia.s1847.
- Singla N, Pong A, Newman K; MD-10 Study Group. Combination oxycodone 5 mg/ibuprofen 400 mg for the treatment of pain after abdominal or pelvic surgery in women: a randomized, double-blind, placebo- and active-controlled parallel-group study. Clin Ther. 2005 Jan;27(1):45-57. doi: 10.1016/j.clinthera.2005.01.010.
- Morrison SR, Magaziner J, McLaughlin MA, Orosz G, Silberzweig SB, Koval KJ, Siu AL. The impact of post-operative pain on outcomes following hip fracture. Pain. 2003 Jun;103(3):303-311. doi: 10.1016/S0304-3959(02)00458-X.
- Schuurmans MJ, Duursma SA, Shortridge-Baggett LM, Clevers GJ, Pel-Littel R. Elderly patients with a hip fracture: the risk for delirium. Appl Nurs Res. 2003 May;16(2):75-84. doi: 10.1016/s0897-1897(03)00012-0.
- Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005 Apr;102(4):822-31. doi: 10.1097/00000542-200504000-00019.
- Beaupre LA, Jones CA, Saunders LD, Johnston DW, Buckingham J, Majumdar SR. Best practices for elderly hip fracture patients. A systematic overview of the evidence. J Gen Intern Med. 2005 Nov;20(11):1019-25. doi: 10.1111/j.1525-1497.2005.00219.x.
- Abbott C. Falls and hip fractures [updated: February 2011]. University of Missouri-Columbia School of Health Professions. Available at: http://www.vhct.org/case4007/index.htm. Accessed September 26, 2011.
- Edelstein DM, Aharonoff GB, Karp A, Capla EL, Zuckerman JD, Koval KJ. Effect of postoperative delirium on outcome after hip fracture. Clin Orthop Relat Res. 2004 May;(422):195-200. doi: 10.1097/01.blo.0000128649.59959.0c.
- Baumann T, Strickland J. Pain Management. In:DiPiro JT, et al., editors. Pharmacotherpay. 7th ed. New York: McGraw-Hill;2008. 989-1002
- Ofirmev [package insert].San Diego, Ca: Cadence Pharmaceuticals; 2011
- Cattabriga I, Pacini D, Lamazza G, Talarico F, Di Bartolomeo R, Grillone G, Bacchi-Reggiani L. Intravenous paracetamol as adjunctive treatment for postoperative pain after cardiac surgery: a double blind randomized controlled trial. Eur J Cardiothorac Surg. 2007 Sep;32(3):527-31. doi: 10.1016/j.ejcts.2007.05.017. Epub 2007 Jul 23.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2011
Primær færdiggørelse (Faktiske)
1. maj 2013
Studieafslutning (Faktiske)
1. maj 2013
Datoer for studieregistrering
Først indsendt
23. januar 2012
Først indsendt, der opfyldte QC-kriterier
24. januar 2012
Først opslået (Skøn)
27. januar 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
30. september 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. september 2014
Sidst verificeret
1. september 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2011-52 (Anden identifikator: CCRRC)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .